# K013677: Modification to: Med-RO Reverse Osmosis System

- Pathway: 510(k) (Special)
- Applicant: Usfilter/Ionpure, Inc.
- Decided: Mar 8, 2002 after 121 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) USFilter/Ionpure, Inc. M-Series Reverse Osmosis Water Purification System: named in the summary without a submission number

## Most influential descendants
- K030652: Medro SPD (2003), 0 descendants of its own

## Indications for use
The USFilter/Ionpure Med-RO™ Reverse Osmosis System is intended to supply water for use in the preparation of dialysate for hemodialysis patients and for other hemodialysis-related procedures such as cleaning, rinsing of equipment, and reprocessing of dialyzers. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001[RD-5: 1992 if applicable]. The Med-RO™ Reverse Osmosis System is intended to be used in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements.

Source page: https://510kreport.com/device/K013677
Methodology: https://510kreport.com/methodology